Products

RETINA-AI Galaxy
RETINA-AI Health
Ophthalmology AI
RETINA-AI Galaxy is an FDA-cleared, AI-powered Software as a Medical Device for autonomous detection of more-than-mild and vision-threatening diabetic retinopathy in primary care settings, providing rapid results with multi-camera compatibility.

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About RETINA-AI Health

RETINA-AI Health is a healthcare AI company dedicated to expanding global healthcare access through advanced AI technology, aiming to enhance both the quality and affordability of specialized medical care. Their flagship product, RETINA-AI Galaxy™, is a Software as a Medical Device (SaMD) that leverages deep learning algorithms to autonomously detect moderate or worse Diabetic Retinopathy (mowDRet) from retinal images. This system is designed for use in primary care settings, providing rapid diagnoses in under 10 seconds, thereby facilitating timely referrals to eye care professionals when necessary.

The company’s strategic goal is to integrate specialized healthcare services into primary care environments, such as family doctor offices, retail clinics, and pharmacies. Beyond diabetic retinopathy, RETINA-AI Health is actively developing a pipeline of products to detect other ophthalmic conditions, including glaucoma and macular degeneration, and is exploring the potential for identifying systemic health risks like cardiovascular disease and dementia through retinal analysis.

Focus Areas

Diabetic Retinopathy Screening AI-driven Ophthalmic Diagnostics Early Detection of Eye Diseases Systemic Chronic Disease Detection via Retina Deep Learning in Healthcare

Business Intelligence

Key InvestorsPrivate investors (80% physicians), Bill Smith (Founder of Shipt)
PartnershipsPartnerships with healthcare providers and insurers (revenue model)
TechnologyRETINA-AI Galaxy™ (web app, Software as a Medical Device - SaMD), cloud-based AI detector, deep learning algorithms, compatible with Centervue DRSPlus, Crystalvue NFC-700, Topcon NW400 robotic cameras, EHR integration
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Specialization: Diabetic Retinopathy Screening
RETINA-AI Health's flagship product, RETINA-AI Galaxy, specializes in the fully-automated, immediate, and on-site screening for moderate or worse Diabetic Retinopathy (mowDRet) in primary care settings. This aims to prevent blindness through early detection and timely treatment.
Specialization: AI-driven Ophthalmic Diagnostics
The company leverages deep learning to automatically detect diabetic retinopathy from retinal images, providing a diagnosis in less than 10 seconds without the need for a human grader or on-site eyecare specialist.
Specialization: Early Detection of Eye Diseases
Beyond diabetic retinopathy, RETINA-AI Health has a product pipeline aimed at the early detection of other conditions such as glaucoma, macular degeneration, cardiovascular risk, and neurological diseases via retinal analysis.
Specialization: Systemic Chronic Disease Detection via Retina
The retina is viewed as a 'window to the body,' and RETINA-AI Health's long-term vision includes using retinal imaging to detect systemic chronic diseases like cardiovascular risk and neurological conditions, aligning with the emerging field of 'oculomics'.
Specialization: Deep Learning in Healthcare
At its core, RETINA-AI Health utilizes advanced deep learning algorithms, trained on interpretations from expert ophthalmologists and retina specialists, to analyze retinal images and provide diagnoses consistent with international classifications.
Key Differentiator: Fully-Automated & Rapid Screening
The RETINA-AI Galaxy system offers immediate, fully-automated diabetic eye screening in the primary care setting, delivering a diagnosis in under 10 seconds. This eliminates the need for a human grader or an eyecare specialist on-site for the initial screening.
Key Differentiator: Multi-Camera Compatibility
RETINA-AI Health is noted for being compatible with multiple robotic fundus cameras from different manufacturers, including Centervue DRSPlus, Crystalvue NFC-700, and Topcon NW400.
Key Differentiator: Ease of Use & Accessibility
The system is designed for ease of use, with robotic cameras that require no manual adjustments, making training simple for any medical assistant without prior eyecare-specific training. This facilitates increased access to specialized healthcare in primary care settings.
Key Differentiator: Value for Primary Care Providers
For PCPs, the system offers a new revenue stream (CPT code 92229, reimbursable by Medicare and major insurers) and helps improve HEDISu00ae Measures & CMS Star Ratings by closing care gaps and preventing blindness.
Technology Stack: Deep Learning Algorithms
The core technology relies on robust deep learning algorithms, trained on diverse datasets and expert knowledge to identify markers of disease.
Technology Stack: Web-Based Software as a Medical Device (SaMD)
The RETINA-AI Galaxy is a web application, functioning as a Software as a Medical Device (SaMD). It requires no downloads or software installation and is supported on modern web browsers.
Technology Stack: Secure & Compliant Infrastructure
The Galaxy system prioritizes security, with data encrypted in storage and transmission, and numerous best-in-class security measures in place.
Physician Tip

For physicians, RETINA-AI Health offers a significant opportunity to streamline diabetic retinopathy screening within the primary care setting, enabling early detection and timely referrals without requiring an ophthalmologist on-site for initial diagnosis. This can lead to improved patient outcomes by preventing vision loss and enhancing patient compliance with screening. The system's ease of use and compatibility with common robotic cameras simplify integration into existing workflows, and the potential for new revenue streams (CPT code 92229) and improved quality metrics (HEDISu00ae Measures & CMS Star Ratings) provides clear practice benefits. Remember that RETINA-AI Galaxy is a screening tool for patients already diagnosed with diabetes, and positive results for moderate or worse DR necessitate immediate referral to an eye care professional for further evaluation and treatment.

RETINA-AI Health's Galaxy platform offers seamless integration with existing Electronic Health Record (EHR) systems. It is compatible with specific robotic fundus cameras: Centervue DRSPlus, Crystalvue NFC-700, and Topcon NW400.

Products by RETINA-AI Health

1 product in the directory

RETINA-AI Galaxy
RETINA-AI Health
Ophthalmology AI
RETINA-AI Galaxy is an FDA-cleared, AI-powered Software as a Medical Device for autonomous detection of more-than-mild and vision-threatening diabetic retinopathy in primary care settings, providing rapid results with multi-camera compatibility.

Reviews & Opinions

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Press & Coverage

PR Newswire
RETINA-AI Health, Inc. Closes $2.6M Bridge Round; Totaling $8.1M Raised to Build Galaxyu2122 Multi-Camera-Compatible Diabetic Retinopathy AI System. Starts Clinical Trial.
RETINA-AI Health, Inc. announced the closing of a $2.6 million bridge financing round, bringing its total raised to $8.1 million for the development of its RETINA-AI Galaxyu2122 v2.0 system, a U.S. patent-protected AI diabetic retinopathy detection system. The company also began enrollment in its Pivotal (Phase III) multi-center prospective clinical trial for the system on November 3, 2022.
2022-12
PR Newswire
RETINA-AI Health, Inc. Announces Positive Pivotal Study Results for the RETINA-AI Galaxyu2122 Autonomous Diabetic Retinopathy Screening Device. Regulatory Application Submitted to the FDA for Clearance.
RETINA-AI Health, Inc. reported positive results from the pivotal study of its RETINA-AI Galaxyu2122, a multi-device compatible autonomous diabetic retinopathy screening device, and has submitted its application to the U.S. Food and Drug Administration (FDA) for clearance. The study results were presented at the Society for Imaging Informatics in Medicine (SiiM)'s Conference on Machine Intelligence in Medical Imaging (CMIMI21).
2021-09
Modern Optometry
RETINA-AI Health Awarded US Patent for AI Detection of Eye Disease
RETINA-AI Health has been granted a U.S. patent for its artificial intelligence (AI) systems designed for the autonomous detection of eye diseases from images. This technology aims to address obstacles in routine screening for conditions like diabetic retinopathy, macular degeneration, and glaucoma, which can lead to irreversible vision loss.
2021-04
PR Newswire
RETINA-AI Health, Inc. is Awarded U.S. Patent for AI Detection of Eye Disease
RETINA-AI Health Inc. announced it has been awarded a U.S. patent for its Artificial Intelligence (AI) systems that autonomously detect eye diseases from images. The patented technology is designed to screen for various eye conditions, including diabetic retinopathy, macular degeneration, and glaucoma, to prevent vision loss.
2021-04
The Blog of RETINA-AI Health, Inc. (Medium)
Artificial Intelligence and Telemedicine in a World of Value-Based Healthcare: A Deep Dive
Dr. Stephen Odaibo, CEO of RETINA-AI Health, Inc., published an article discussing the impact of artificial intelligence and telemedicine in value-based healthcare, specifically focusing on diabetic retinopathy screening. The article delves into the CMS's final rule for CY 2021 Physician Fee Schedule, including the decision on CPT code 92229 for AI detection of diabetic retinopathy.
2020-12
Pulse 2.0
RETINA-AI Health Raises $5.2 Million To Use AI For Detection Of Diabetic Retinopathy
RETINA-AI Health, a company specializing in AI for healthcare outcomes, secured $5.2 million in funding to advance its artificial intelligence technology for detecting diabetic retinopathy. The funding round was primarily supported by private investors, with 80% being physicians, and included Bill Smith, founder of Shipt.
2020-08
PR Newswire
RETINA-AI Health, Inc. Raises $5.2M for AI Detection of Diabetic Retinopathy
RETINA-AI Health, Inc. announced it raised $5.2 million in Series A financing for AI screening of diabetic retinopathy. The capital, primarily from private investors including physicians and business leaders like Bill Smith, will be used to advance the company's retina-based AI detection technology through FDA clearance.
2020-08
The Ophthalmologist
Ophthalmic Frontiers: AI
Dr. Stephen Odaibo, founder and CEO of RETINA-AI Health, discusses his extensive background in mathematics, computer science, and medicine, which led him to build the world's first mobile AI app for eye care providers and establish RETINA-AI Health. He highlights the company's focus on innovating and developing new AI technologies in ophthalmology.
2019-12

Frequently Asked Questions

RETINA-AI Health's flagship product is RETINA-AI Galaxy, an FDA-cleared, fully-automated AI system for on-site diabetic retinopathy screening. It provides a diagnosis for moderate or worse Diabetic Retinopathy (mowDRet) in less than 10 seconds within primary care settings, eliminating the need for an on-site human grader or eyecare specialist.
The RETINA-AI Galaxy system uses deep learning algorithms, trained by expert ophthalmologists, to automatically analyze retinal images for signs of diabetic retinopathy. This enables early detection of moderate or worse Diabetic Retinopathy, allowing for timely referral to an eye care professional and potentially preventing vision loss.
While the current RETINA-AI Galaxy product is specifically indicated only for the autonomous detection of diabetic retinopathy, RETINA-AI Health has a pipeline of future products aimed at detecting other conditions such as glaucoma, macular degeneration, cardiovascular risk, and neurological diseases through retinal imaging.
RETINA-AI Galaxy is the first US FDA-cleared technology for autonomous detection of moderate or worse Diabetic Retinopathy and vision-threatening Diabetic Retinopathy across multiple camera brands. The company is also ISO 13485:2016 Certified and HIPAA Compliant, ensuring high standards for medical device quality and patient data security.
Implementing RETINA-AI Galaxy can add a new revenue stream for primary care providers, as it is reimbursable by Medicare and major healthcare insurance providers using CPT code 92229. This also helps improve HEDISu00ae Measures and CMS Star Ratings by closing care gaps and reducing costs associated with preventable blindness.
The RETINA-AI Galaxy system is designed for ease of use, requiring only short training for any medical assistant without prior ophthalmic experience. It is a web application, requiring no software installation, and offers seamless integration with existing Electronic Health Record (EHR) systems.
RETINA-AI Health, founded in 2017, has raised over $10 million in funding, indicating a level of financial stability. The RETINA-AI Galaxy system is compatible with robotic cameras from Centervue, Crystalvue, and Topcon, facilitating its integration into various clinical workflows.

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